An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
研究概览
简要总结
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between 6 and 17 years of age
- •Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
- •Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
- •Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
- •Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
- •Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria
排除标准
- •I.Q. < 70
- •DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
- •History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- •Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
- •Pregnant or nursing females
- •Organic brain disorders
- •Uncorrected hypothyroidism or hyperthyroidism
- •Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
- •History of renal or hepatic impairment
- •Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
- •Current diagnosis of schizophrenia
- •History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
- •Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
- •A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
- •Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.
研究组 & 干预措施
Buspirone
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
干预措施: Buspirone (Drug)
结局指标
主要结局
Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
时间窗: Baseline to week 8
The PARS is a clinician-rated scale to be used with parents and children. It consists of 57 items and has two sections: a symptom checklist (first 50 items) and severity items (last 7 items). The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7 severity items are used to determine severity of symptoms and the PARS total score. The total score for the PARS is derived by summing the 7 severity items; total score ranges from 0 to 35, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in PARS scores. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint
时间窗: Week 8 (study endpoint)
The CGI-Anxiety-I is a clinician rated measure of anxiety improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). This outcome reports the number of participants who scored ≤2 (improved or very much) at study endpoint.
Treatment Responder
时间窗: Week 8 (study endpoint)
Treatment responder is defined by a Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) score ≤ 2 (improved or very much improved) and a ≥30% reduction on the Pediatric Anxiety Rating Scale (PARS) from baseline.
次要结局
未报告次要终点
研究者
Gagan Joshi
Principal Investigator
Massachusetts General Hospital